Salary CNY250000 - CNY350000 per annum
Consultant Doris Dai
Date posted 20 April 2018No.1539 West Nanjing Road Shanghai 200040 Robert Walters China
Responsible for new product registration plan and operation in China.
- Responsible for new product registration plan and operation in China. Lead RA vendors to integrate internal/external resources and to interact with CDE/CFDA and finally obtain IND/NDA approval.
- Responsible for pre-clinical stage and clinical trial phase I and phase II regulatory plans, submission, and approval of pre-clinical and clinical trial in China.
- Responsible for establishing and management of regulatory process in China and driving performance as measured by expeditious development of plans, regulatory submissions and approvals in China.
- Monitor operational progression of IND application authorisation activities with regulatory agencies or committees.
- Maintain relationship and communication with the regulatory agencies or committees to expedite authorisation approvals and other operational regulatory interventions.
- Ensures all documents submitted to regulatory agencies are complete, well organised, in regulatory compliance, and presented in a manner that facilitates agency review.
- Responsible for maintaining records of regulatory submissions and communications with the relevant regulatory agencies.
- Set up and develop internal RA SOPs, RA vendor’s management including vendor selection and auditing.
- Work with CMC and Clinical trial colleagues to develop strategies and provide regulatory review for materials.
- Also working as a member of TCB leadership team together to win business.
- Develop and maintain excellent working relationships with health authorities; identify regulatory risks for investigational and develop strategies to minimise risks during the whole process.
- New drug RA experience